Immunogenicity against therapeutic proteins is a clinical issue and can greatly reduce safety and efficacy of protein based therapy. Antibody-based immune response can not only alter pharmacokinetics but also abrogate the pharmacological activity of the protein. There are several approaches that are undertaken to minimize immunogenicity including development of less immunogenic formulation, modifying treatment options, use of steroids and delivery approaches. Each approach has limitations and an effective approach to minimize immunogenicity has not been achieved.
In some instances, it has been observed that even if an individual is not immune intolerant during a treatment regimen, the individual may develop immune intolerance over time. In such instances, it would be desirable to develop approaches to suppress the later developed immune intolerance.